Medicaid patients with HCV more often denied DAA therapy

Issue: December 2015

SAN FRANCISCO — Absolute denial of direct-acting antiviral prescriptions occurred in 16% of all patients, but 46% of patients with Medicaid. Those with Medicaid also had a longer time until they were filled, according to a Late Breaker presentation delivered during The Liver Meeting 2015.

“The implications of these denials of DAA therapy remain unclear. But, it certainly may be that they have downstream adverse outcomes for both patients and providers ,” Vincent Lo Re, MD, MSCE, said during his presentation.

Lo Re presented a prospective cohort study with multivariate analysis of 2,321 patients from a specialty pharmacy that services Delaware, New Jersey, Maryland and Pennsylvania. The data was taken from the first 6 months of the DAA era, Lo Re said, using November 1, 2014, and April 30, 2015, as their time period.

Vincent Lo Re

Patients were classified as having state-based Medicaid (n = 503), Medicare (n = 795) or commercial insurance (n = 1,023) and the pharmacy reported more than 80% of patients in each insurance coverage were prescribed Harvoni (ledipasvir/sofosbuvir, Gilead Sciences) with or without ribavirin. Other regimens prescribed were Sovaldi (sofosbuvir, Gilead Sciences), sofosbuvir plus Olysio (simeprevir, Janssen Therapeutics), Viekira Pak (ombitasvir/paritaprevir/ritonavir plus dasabuvir, AbbVie) and pegylated interferon plus ribavirin plus sofosbuvir.

Compared to the overall cohort and Medicaid patients, those patients covered by Medicare were only absolutely denied 5% of the time and those with commercial insurance experienced absolute denial 10% of the time (P < .001 for both when compared with Medicaid).

“Absolute denial of DAA therapy occurred in 16% of patients who were prescribed a DAA treatment during the observation period. Most notably, 46% of patients covered by Medicaid were absolutely denied, significantly more so than those covered by commercial insurance or Medicare,” Lo Re said.

The factors associated with denial of DAAs were Medicaid, lack of cirrhosis and prescription given in the earlier half of the study. For those covered by Medicaid, lack of medical necessity and incomplete data to determine medical need were the most commonly cited reasons for denial. These reasons were cited more often by Medicaid than Medicare or commercial insurances.

“Interestingly, those prescribed in the initial 3 months of the observation period more commonly were likely to be denied than those in the latter period,” Lo Re said.

Days to DAA fill were also shown to be much greater with Medicaid than with Medicare or commercial insurance with 24 days vs. 14 days with both Medicare and commercial insurance (P < .001 for both). This mainly stemmed from those that were denied at first and eventually were filled, as Medicaid averaged 46 days in that process with Medicare and commercial insurance averaging 35 and 32 days, respectively (P < .001 and P = .003, respectively). Without denial, all three entities were similar.

“Medicaid patients had a significantly longer time to prescription filled,” Lo Re said. “U.S. Medicaid coverage and absence of cirrhosis were the factors most strongly associated with denial of DAA treatment.” – by Katrina Altersitz

Reference:

Lo Re V, et al. Abstract LB-5. Presented at: The Liver Meeting; Nov. 13-17, 2015; San Francisco.

Disclosures: Lo Re reports no relevant financial disclosures. Please see study abstract for a list of all authors’ disclosures.

Editor's note: This article has been updated for clarity in the data set.